I

103D CONGRESS

2D SESSION H. R. 5222

To provide for nonanimal acute toxicity testing by the Federal Government.

IN THE HOUSE OF REPRESENTATIVES

OCTOBER 6, 1994

Mr. LANTOS (for himself, Mr. ACKERMAN, Mr. BEILENSON, Mr. BROWN of

California, Mr. DEFAZIO, Mr. DELLUMS, Mr. GEJDENSON, Mr. HAMBURG, Mr. HOCHBRUECKNER, Mr. JOHNSON of South Dakota, Mr.

JOHNSTON of Florida, Mr. KLECZKA, Mr. MANTON, Mr. MINETA, Mr.

MORAN, Mr. NEAL of Massachusetts, Mr. RAVENEL, Ms. ROYBAL-ALLARD, Mr. SHAYS, Mr. SWETT, Mr. SWIFT, and Mr. TOWNS) introduced

the following bill; which was referred to the Committee on Energy and

Commerce

A BILL

To provide for nonanimal acute toxicity testing by the

Federal Government.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Consumer Products

5 Safe Testing Act’’.

6 SEC. 2. FINDINGS AND POLICY.

7 (a) FINDINGS.—The Congress finds that—
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1 (1) nonanimal acute toxicity tests have been de2 veloped in recent years that have shown a level of re3 liability sufficient for the reduction or replacement

4 of animal acute toxicity tests such as the Draize test

5 for many products regulated by the Federal Govern6 ment;

7 (2) many manufacturers have found nonanimal

8 acute toxicity tests to be adequate for evaluating the

9 safety of products for the purposes of complying

10 with Federal regulations or guidelines;

11 (3) the Federal Government has discouraged

12 the use of these alternatives through regulations

13 that mandate or encourage the use of animal acute

14 toxicity tests, or by not prescribing other, less costly,

15 more accurate and humane alternatives;

16 (4) many manufacturers are reluctant to use

17 nonanimal tests without encouragement from the

18 Federal Government; and

19 (5) private industry and the consumer will ben20 efit from the promotion of alternative methods of

21 testing when these alternatives are as accurate and

22 more humane than animal tests.

23 (b) POLICY.—Federal departments and agencies shall

24 encourage the development and use of product testing pro25 cedures that accurately reflect the acute health effects on
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1 humans of certain products, including consumer products

2 and products containing hazardous or toxic substances,

3 but which do not rely upon animals.

4 SEC. 3. FEDERAL ACTION.

5 (a) REVIEW OF REGULATIONS, GUIDELINES, OR

6 RECOMMENDATIONS CONCERNING THE DRAIZE TEST

7 AND OTHER ANIMAL ACUTE TOXICITY TESTS.—Not later

8 than one year after the date of enactment of this Act, each

9 Federal department or agency head shall—

10 (1) review and evaluate any regulation, guide11 line, or recommendation issued by that department

12 or agency which requires, recommends, or encour13 ages the use of the Draize or other animal acute tox14 icity test for the purpose of evaluation of the safety

15 of a regulated product;

16 (2) review and evaluate nonanimal alternatives

17 with the potential for partial or full replacement of

18 the Draize or other animal acute toxicity test for

19 some or all of the products regulated; and

20 (3) promulgate regulations, guidelines, or rec21 ommendations that specify a nonanimal acute tox22 icity test or battery of tests should be used instead

23 of an animal acute toxicity test unless that Federal

24 department or agency head determines that the

25 nonanimal acute toxicity test or battery of such tests
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1 is less likely to predict the acute health effects on

2 humans of a product than the animal acute toxicity

3 test.

4 (b) ANIMAL ACUTE TOXICITY TESTS.—If a deter5 mination is made that no nonanimal acute toxicity test

6 or battery of tests is as likely to predict the human reac7 tion to the regulated product as the Draize or other animal

8 acute toxicity test, the appropriate Federal department or

9 agency head shall publish in the Federal Register an ex10 planation of all options considered and the justification for

11 continuing the animal acute toxicity test, which shall be

12 subject to public comment.

13 (c) PERIODIC REVIEW OF ANIMAL ACUTE TOXICITY

14 TESTING REGULATIONS.—At least every 2 years (begin15 ning 3 years after the date of enactment of this Act), each

16 Federal department or agency head, after considering the

17 most recent technological advances available, shall deter18 mine whether continued use of any animal acute toxicity

19 test is justified. If a Federal department or agency head

20 determines that such use is justified, then that Federal

21 department or agency head shall publish an explanation

22 and justification of such continued use in the Federal Reg23 ister, which shall be subject to public comment.
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1 SEC. 4. APPLICATION.

2 This Act shall not apply to regulations, guidelines,

3 or recommendations related to medical research.

4 SEC. 5. DEFINITIONS.

5 For purposes of this Act:

6 (1) ANIMAL.—The term ‘‘animal’’ means any

7 vertebrate.

8 (2) ANIMAL ACUTE TOXICITY TEST.—The term

9 ‘‘animal acute toxicity test’’ means an acute toxicity

10 test on animals, including (but not limited to) the

11 Draize eye or skin irritancy test, LD–50 test, ap12 proximate lethal dose test, and the limit test.

13 (3) FEDERAL DEPARTMENT OR AGENCY

14 HEAD.—The term ‘‘Federal department or agency

15 head’’ means the head of a Federal department or

16 agency who—

17 (A) has authority to promulgate regula18 tions, guidelines, and recommendations with re19 spect to procedures to be used in the safety

20 testing by manufacturers of products, including

21 consumer products, veterinary products, and

22 products containing hazardous or toxic sub23 stances; or

24 (B) licenses or approves products, labeling

25 requirements or the transportation of products

26 based on the results of these tests.
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1 (4) MEDICAL RESEARCH.—The term ‘‘medical

2 research’’ means research related to the causes, di3 agnosis, treatment, or control of physical or mental

4 impairments of humans or animals. The term does

5 not include the testing of a product to determine its

6 toxicity for the purpose of complying with protocols,

7 recommendations, or guidelines for testing required,

8 recommended, or accepted by a Federal regulatory

9 agency for a product introduced in commerce.

10 (5) NONANIMAL ACUTE TOXICITY TEST.—The

11 term ‘‘nonanimal acute toxicity test’’ means an

12 acute toxicity test not conducted on animals. Such

13 tests include (but are not limited to) cell culture,

14 computer modeling, protein alteration, and

15 chorioallantoic membrane techniques.

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